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NCT07713277

Overview

NCT ID: NCT07713277
Lead Sponsor: Azienda ULSS 8 BericaOTHER
Official Title: A Bond That Nurtures: Neonatal and Maternal Outcomes of Intact Cord Placental Delivery vs Delayed Cord Clamping
Brief Summary: The management of the third stage of labour plays a critical role in neonatal transition. Uninterrupted Intact Cord Clamping (UICC), is a clinical approach where the umbilical cord remains unclamped until the placenta is spontaneously expelled. This method aims to facilitate the maximum physiological transfer of placental blood to the newborn.

While Delayed Cord Clamping (DCC)-typically defined as clamping between 1 and 3 minutes or until pulsations cease-is widely supported by literature for its ability to improve neonatal iron stores and reduce morbidity and mortality without increasing maternal-foetal risk, there is currently a lack of robust evidence regarding the systematic practice of Uninterrupted Intact Cord Clamping (UICC), defined as clamping only after placental delivery. This gap in the literature necessitates a thorough investigation into the potential benefits and safety of UICC.
Conditions

Status and Timeline

Status: Active, not recruiting
Last Update Posted: Jul 20, 2026Actual
Start Date: Apr 15, 2026Actual
Primary Completion Date: Jul 31, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

Singleton pregnancy (≥34+0 weeks of gestation).

Spontaneous eutocic vaginal delivery.

Healthy newborn with a birth weight of ≥2500 grams (appropriate for gestational age).

Informed consent signed by both the patient and her partner.

Exclusion Criteria:

Maternal Medical Conditions

Chronic or Pregnancy-Induced Hypertensive Disorders: Including chronic hypertension, pre-eclampsia, and HELLP syndrome.

Systemic Diseases: Pre-existing autoimmune diseases, significant cardiovascular diseases, or metabolic disorders that may interfere with placental function.

Haematological Disorders: Known maternal coagulopathies, severe anaemia (Haemoglobin < 8 g/dL), or other blood dyscrasias.

Obstetric Complications and Emergencies

Placental Anomalies: Suspected or confirmed placental abruption, placenta previa, or morbidly adherent placenta (accreta/increta/percreta).

Acute Intrapartum Complications: Umbilical cord prolapse, suspected chorioamnionitis (intra-amniotic infection), or significant antepartum haemorrhage.

Operative or Instrumental Delivery: Any requirement for urgent operative vaginal delivery (vacuum or forceps) or conversion to Emergency Caesarean Section.

Pre-existing Risk for PPH: History of severe Postpartum Haemorrhage in previous pregnancies.

Neonatal Factors

Acute Neonatal Distress: Requirement for immediate neonatal resuscitation at birth that precludes waiting for placental expulsion.

Congenital Anomalies: Presence of major congenital malformations or chromosomal abnormalities.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 1,979Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: No data available
Locations: Ospedale San Bortolo

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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